Vaccines, Blood & Biologics
Medical Device Notification: HIV-1/HIV-2 Plus O EIA Testing Software-DiaSporin, Inc
DATE NOTIFICATION INITIATED:
May 13, 2004
HIV-1 / HIV-2 Plus O EIA Testing Software
An error was contained on the ETI-LAB Applications disk for programming the BioRad HIV-1/HIV-2 Plus O assay. The error induced specimen and conjugate incubation temperatures for the assay to remain at ambient temperature rather than the required 37°C temperature. Consignees will receive replacement disks.